Quantra QPlus in Pediatric Cardiovascular Procedures

NCT07597278 | Not Yet Recruiting FDA Device

• 1 other identifier: HEMCS-051
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.

Conditions

Blood Loss, Surgical

Keywords

Viscoelastic testing; Quantra; QPlus Cartridge; Pediatric; Cardiovascular surgery

Outcome Measures

Primary Outcomes (8)

• Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT

  Coagulation function assessed by Quantra and ROTEM sigma

  3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT

  Coagulation function assessed by Quantra and ROTEM sigma

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10

  Coagulation function assessed by Quantra and ROTEM sigma

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10

  Coagulation function assessed by Quantra and ROTEM sigma

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus CT to TEG 6S CK-R

  Coagulation function assessed by Quantra and TEG 6S

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus CTH to TEG 6S CKH-R

  Coagulation function assessed by Quantra and TEG 6S

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus CS to TEG 6S CKH-MA

  Coagulation function assessed by Quantra and TEG 6S

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

• Correlation of QPlus FCS to TEG 6S FFH-MA

  Coagulation function assessed by Quantra and TEG 6S

  3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Study Arms (1)

Pediatric patients

Pediatric patients undergoing cardiovascular procedures

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.

Pediatric patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric patients \<18 years of age that are undergoing cardiovascular procedures.

You may qualify if:

• Subject is \<18 years of age.
• Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
• Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.

You may not qualify if:

• Corrected gestational age \<37 weeks.
• Subject is enrolled in a study that might confound the result of the proposed study.
• Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (3)

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Central Study Contacts

Deborah Winegar

CONTACT

9192446990; dwinegar@hemosonics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)